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Standard Operating Procedure: Management Review

Document ID SOP-005
Title Management Review
Revision 1.0
Effective Date [DATE]
Author [AUTHOR]
Approved By [APPROVER]
Department Quality Assurance

1. Purpose

To establish a systematic process for top management to review the Pediatric Clinical Research Quality Management System to ensure its continuing suitability, adequacy, effectiveness, and alignment with the organization's strategic direction and commitment to child participant protection.

2. Scope

This procedure applies to periodic reviews of the entire Quality Management System by top management, including pediatric research operations, regulatory compliance, and continuous improvement initiatives.

3. Definitions

Term Definition
Management Review Periodic evaluation of QMS by top management
Top Management Executive leadership with authority over QMS
QMS Quality Management System
KPI Key Performance Indicator

4. Responsibilities

4.1 Chief Executive Officer / President

  • Chairs management review meetings
  • Ensures management review conducted
  • Makes decisions on QMS improvements
  • Allocates resources
  • Ensures pediatric research mission alignment

4.2 Quality Assurance Manager

  • Schedules and coordinates management reviews
  • Prepares management review agenda and materials
  • Compiles metrics and performance data
  • Documents review proceedings
  • Tracks action items
  • Presents pediatric research quality metrics

4.3 Department Heads

  • Provide input and data for their areas
  • Participate in review meetings
  • Implement assigned action items
  • Report on pediatric research operations

4.4 Principal Investigators (as applicable)

  • Provide study-specific updates
  • Report pediatric safety trends
  • Discuss challenges in pediatric recruitment and retention

5. Procedure

5.1 Management Review Frequency

  1. Formal management reviews conducted at least annually

  2. Additional reviews conducted when:

    • Major regulatory changes occur (especially pediatric regulations)
    • Significant organizational changes happen
    • Critical quality issues arise
    • Serious pediatric safety events occur
    • Major pediatric studies initiate or complete

  3. Interim quality reports provided quarterly between formal reviews

5.2 Review Planning

  1. Quality Assurance Manager schedules review at least 4 weeks in advance

  2. Identify participants:

    • CEO/President
    • Quality Assurance Manager
    • Clinical Operations Manager
    • Regulatory Affairs Manager
    • Principal Investigators (as needed)
    • Department Heads
    • Pediatric Research Specialist

  3. Distribute agenda and preparation materials 2 weeks prior

  4. Request input from departments 1 week prior

5.3 Review Inputs

The management review shall include analysis of:

5.3.1 QMS Performance

  • Status of actions from previous management reviews
  • Changes in internal and external issues affecting QMS
  • Customer/sponsor satisfaction and feedback
  • Quality objectives achievement
  • Process performance metrics
  • Product/service conformity

5.3.2 Pediatric Research Operations

  • Number and status of active pediatric studies
  • Pediatric participant enrollment and retention rates
  • Age distribution of participants across studies
  • Protocol compliance for pediatric studies
  • Assent and consent processes effectiveness

5.3.3 Audit Results

  • Internal audit findings and trends
  • Sponsor audit results
  • Regulatory inspection outcomes
  • Pediatric-specific audit observations
  • Compliance with 45 CFR 46 Subpart D and 21 CFR 50 Subpart D

5.3.4 Nonconformities and Corrective Actions

  • CAPA metrics (open, closed, overdue)
  • Protocol deviations and violations
  • Trending by category
  • Repeat findings
  • Pediatric safety-related CAPAs
  • Assent/consent issues

5.3.5 Monitoring and Measurement Results

  • Key performance indicators (KPIs):
    • Participant safety metrics (AEs, SAEs in pediatric population)
    • Enrollment vs. targets for pediatric studies
    • Protocol deviation rates
    • Data quality metrics
    • Training compliance
    • Document control effectiveness
    • Sponsor/customer satisfaction scores
    • Family satisfaction with pediatric research experience

5.3.6 Pediatric Safety Data

  • Adverse events summary by severity and age group
  • Serious adverse events requiring regulatory reporting
  • Data Safety Monitoring Board (DSMB) recommendations
  • Unanticipated problems involving risks
  • Growth and development monitoring results
  • Long-term safety follow-up status

5.3.7 Training and Competence

  • Training completion rates
  • GCP certification status
  • Pediatric research training completion
  • Competency assessment results
  • Training effectiveness
  • Knowledge gaps identified

5.3.8 Regulatory Compliance

  • FDA/EMA/regulatory authority communications
  • IRB/Ethics Committee findings
  • Regulatory submissions status
  • Changes to pediatric regulations (PREA, BPCA, etc.)
  • Warning letters or inspectional observations (industry-wide)

5.3.9 Resource Adequacy

  • Staffing levels and qualifications
  • Facilities and equipment suitability for pediatric research
  • Technology and systems adequacy
  • Budget vs. actual
  • Pediatric specialist availability
  • Child life support services

5.3.10 Opportunities for Improvement

  • Process improvement initiatives
  • Technology enhancements
  • Best practices identified
  • Lessons learned from completed pediatric studies
  • Feedback from pediatric research community

5.3.11 Changes Affecting QMS

  • Organizational changes
  • New service offerings
  • Regulatory requirement changes
  • Standard updates (ICH guidelines)
  • New pediatric research areas

5.4 Review Meeting

  1. Quality Assurance Manager facilitates meeting

  2. Review each input systematically using agenda

  3. Discuss trends, successes, and challenges

  4. Address pediatric-specific considerations:

    • Adequacy of age-appropriate procedures
    • Effectiveness of assent processes
    • Family engagement and satisfaction
    • Pediatric safety monitoring effectiveness
    • Compliance with pediatric regulations

  5. Identify systemic issues requiring attention

  6. Make decisions on:

    • QMS improvements needed
    • Resource allocation
    • Quality objectives revision
    • Process changes
    • Training needs
    • Pediatric research capability enhancements

  7. Document all decisions and action items

5.5 Review Outputs

Management review shall produce:

  1. Decisions and Actions related to:

    • Quality Management System improvements
    • Pediatric research process enhancements
    • Resource needs (personnel, facilities, equipment)
    • Quality objectives updates
    • Policy revisions
    • Training initiatives
    • Technology investments

  2. Action Items with:

    • Specific action description
    • Responsible person assigned
    • Target completion date
    • Expected outcome
    • Priority level

  3. Quality Objectives for next period

  4. Resource Commitments for improvements

5.6 Documentation

  1. Quality Assurance Manager prepares Management Review Report including:

    • Date and attendees
    • Review inputs summary
    • Discussion highlights
    • Decisions made
    • Action items (with owners and due dates)
    • Updates to quality objectives
    • Resource commitments
    • Pediatric research strategic directions

  2. Report issued within 2 weeks of meeting

  3. Report distributed to:

    • All attendees
    • Department heads
    • Board of Directors (executive summary)

  4. Report retained per retention requirements

5.7 Follow-up

  1. Quality Assurance tracks action items

  2. Status updates provided in quarterly reports

  3. Overdue items escalated to top management

  4. Completed items verified

  5. Action item status reviewed in next management review

6. Key Performance Indicators (KPIs)

Suggested KPIs for pediatric research operations:

Safety and Participant Protection

  • Adverse event rate by age group
  • Serious adverse event rate
  • Protocol violations (especially affecting child safety)
  • Time to safety report submission
  • DSMB recommendations implemented

Quality and Compliance

  • Audit findings by severity
  • CAPA on-time closure rate
  • Protocol deviation rate
  • Training compliance rate
  • Document control effectiveness

Operational Efficiency

  • Pediatric participant enrollment rate
  • Screen failure rate by age group
  • Study milestone achievement
  • Query resolution time
  • Family retention rate

Regulatory and Sponsor Relations

  • Regulatory submission timeliness
  • Sponsor monitoring findings
  • IRB approval timeliness
  • Sponsor satisfaction scores

Family Experience

  • Family satisfaction survey results
  • Assent comprehension assessment
  • Complaints or concerns raised
  • Study withdrawal reasons

7. Continuous Improvement

Management review drives continuous improvement through:

  • Identification of improvement opportunities
  • Resource allocation for improvements
  • Process optimization initiatives
  • Technology adoption
  • Training program enhancements
  • Best practice implementation
  • Benchmarking against pediatric research standards

8. Related Documents

  • FRM-008 Management Review Report Template
  • Quality Objectives Document
  • Annual Audit Program
  • CAPA Summary Reports
  • Training Compliance Reports
  • Pediatric Safety Monitoring Reports

9. References

  • ISO 13485:2016 Section 5.6 (Management Review)
  • ICH-GCP E6(R2) Section 5 (Sponsor)
  • 45 CFR 46.103 (Assurance of Compliance)
  • 21 CFR 312.56 (Review of Ongoing Investigations)

Revision History

Rev Date Description Author
1.0 [DATE] Initial release [AUTHOR]
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